SME Projects

3.4 SME Projects

Czech-Republic

FGFSTAB

Industrial Production of Stable

Fibroblast Growth Factors for Regenerative Medicine and Related Research Areas Coordinator: Enantis s.r.o.

Link: https://cordis.europa.eu/project/id/756471 Abstract

The FGFSTAB project closes the gap between Enan-tis knowledge and experEnan-tise on protein engineering and the commercial applications of stable fibroblast growth factors (FGFs). FGFs are essential to the em-bryonic development, maintain tissue homeostasis, may slow down ageing of the organisms, and pri-marily promote angiogenesis and wound healing.

FGFs see the greatest application in the care and treatment of chronic skin ulcers, but also find use in surgical and trauma wound healing. The global wound care market is rapidly growing due to the in-creasing aging population and growing incidences of obesity and diabetes. Advanced wound dressings, such as those involving growth factors, play an im-portant role in current regenerative medicine and companies around the world have started investing heavily in research and development of growth fac-tor-based products. However, despite clinical value, applications of FGFs are limited by the fact that nat-ural proteins have poor thermal stability and a short half-life in the circulation; they are often cleared from the body within hours, if not minutes, thus necessitating frequent administrations during the course of treatment, which goes hand in hand with

a higher risk of adverse effects and lower cost-effec-tiveness of the protein therapy. The key objective of the FGFSTAB project is to use an innovative techno-logical platform, based on the application of Enantis proprietary protein optimisation concept FireProt, to increase FGF stability under various stress conditions.

Additional challenges including the high cost of pro-duction, current Good Manufacturing Practice, de-velopment of delivery systems for safe and effective wound healing, and pre-clinical testing to support future clinical trials and marketing authorisation, will be targeted as well. Financial support provided within SME Instrument Phase 2 will help us close the gap from demanding biotechnological development to the targeted industrial application in regenerative medicine.

Personal experience

“Across much of the developed world, popu-lations are becoming older, more obese and increasingly prone to chronic diseases such as diabetes. As a result, the global wound-care market is rapidly evolving, with innovative fibro-blast growth factor (FGF) products driving the field of regenerative medicine. By addressing the poor stability of selected FGFs, the EU-fund-ed FGFSTAB project was implementEU-fund-ed to in-crease their commercial use within the thera-peutic arena. As a direct result of the FGFSTAB project, Enantis has significantly expanded and strengthened its capability, efficiency, and com-petitiveness. In September 2018, Enantis signed an important distribution agreement with a leading life sciences company.

Enantis tried three times before successfully receiving the SME Instrument, Phase I (2015) funding worth EUR 50,000 for preparing a robust business plan. Subsequent SME Instru-ment Phase 2 (2017– 2019) funding worth EUR 1 million enabled Enantis to develop a product which is now available globally. Enantis became the first Czech company to receive funding un-der both phases of the SME Instrument.”

RADARR 2

Rapid and durable asphalt road repairs 2 Coordinator: FUTTEC a.s.

Link: https://cordis.europa.eu/project/id/873538 Abstract

A revolution in asphalt road maintenance Europe’s road system needs continuous and costly repair to be maintained, but usually results in short-term fixes. The EU-funded RADARR 2 project aims to introduce more durable repair results for faster application. Its solution will be more effective and economical in comparison with the currently applied technologies. Specifically, the project supports test-ing and the commercialisation process of the micro-wave technology for asphalt pavement maintenance elaborated by FUTTEC Corporation. The RADARR 2 project will use a microwave machine (FT3 device) and a polymerisation agent for the homogenous fix-ation of pavements cracks. It guarantees a long-life span for technological joints, and what is more, can be used independently of weather conditions and be tailored to consumers’ needs.

Objective

The overall objective of the project RADARR 2 (RAPID AND DURABLE ASPHALT ROAD REPAIRS 2) is to com-mercialise the unique microwave technology for as-phalt road repairs. The novelty of the technology lies in a completely new approach to pavement repair offering great advantages for various kinds of cus-tomers like maintenance companies, highway main-tenance centres, regions and municipalities, associ-ations of municipalities, private highway operators

and construction companies. Microwave technology represents a revolution in asphalt road maintenance.

It brings durable repair results, faster application and it is simple, more effective and economical in comparison with the currently applied technologies.

The application of microwave technology enables elimination of a non-homogenous connection of the repaired spot resulting in significant extension of the life span of repairs. The extended life span of repairs means great savings for infrastructure owners and operators and consequently it means a great market opportunity for the FUTTEC Corporation. Another great competitive advantage of the FUTTEC tech-nology is the possibility of performing repairs dur-ing winter season, when competitive solutions are highly limited by the weather and unable to offer results of comparable quality. The outcome of the RADARR 2 project will be tested by the microwave machine FT3 that is ready for commercialisation. The FT3 machine represents a functional versatile device, which is using the microwave energy for repairs of cracks in asphalt surfaces (potholes) and is able to connect technological joints of the new and repaired asphalt using a polymerisation agent. The machine will be adapted to customers’ needs and preferences in order to maximize the commercialisation poten-tial. The FT3 machine has the potential to change the approach to asphalt repairs and to offer a technolog-ically advanced solution suitable for the 21st century.

Personal experience

“We started the project preparation about 2 months in advance. As we do not have any partner in the consortium, it was not necessary to coordinate the preparation with the partners, which would certainly significantly extend the project preparation period. We were successful with the 6th attempt under the SME Instrument, which issues an identical call for SMEs 4 times a year. We have repeatedly received a Seal of Excellence for earning more than 13 points out of 15 in the evaluation.

The biggest challenge in writing the project proposal was to well balance the individual chapters within the page limit of the application. Explaining the essence of the business plan in a simple and convincing way and demonstrating the European market potential of the newly developed technology was another challenging task we had to deal with.

Regarding the implementation, we are so far in the first half of the project implementation and the big-gest challenge was to solve the problems related to the COVID-19 pandemic. The management of the development work and the coordination of necessary suppliers (e.g. from Italy and Germany) caused a sig-nificant delay compared to the planned project sched-ule in one work package focused on adapting the FT3 microwave device for repairing asphalt surfaces ac-cording to target customers. When we had to respond to the situation activities, their sequence, including the initiation of the project change and part of mi-nor activities, we decided to move to a subcontractor, which should help the project team catch up with the delay caused by the COVID-19 pandemic.

The funding for our project provided by H2020 helped us not only start financially demanding activities aimed at commercialising our microwave technology but also to present our technology to potential foreign investors and customers. We got the opportunity to consult our business and our business strategy with experienced professionals as well as the support from H2020 associated with publicity and prestige.”

Slovakia

NanoScreen

Disruptive portable device for pre-screening of Persistent Organic Pollutants – POPs in food products and water

Coordinator: SAFTRA Photonics s.r.o., Pavol Jozef Šafárik University – Prof. Pavol Miskovsky

Link: https://cordis.europa.eu/project/id/766742 Abstract

Persistent organic pollutants (POPs) are organic compounds produced by human action resistant to environmental degradation and their bioaccumula-tive capacity and toxicity can cause harmful health effects, e.g. cancer. Hence, they have become global threats for humans and the environment. The most extended analytic methods used nowadays for de-tecting POPs are gas chromatography and/or mass spectroscopy to separate and identify them. These methods are expensive – EUR 1,000/sample – and time-consuming (24h), they require laborious sam-ple preparation and a well-equipped laboratory.

Consequently, there is a great demand to increase the number of water and food quality tests if availa-ble for a lower price and shorter time.

SAFTRA PHOTONICS will bring to market Nano-Screen – a portable nano-optical sensing chip for pre-screening purpose that detects food or water contamination by POPs. We will offer a rapid meth-od (10 minutes) to detect the most important POPs (ppb) present in food products and water, carrying out an in situ analysis for less than EUR 100 per sample. By putting the NanoScreen solution to the

European, Japanese and USA market, by 2023 we expect to sell 55,000 chips with the revenue of EUR 4,800,000 (27% Y/Y growth) and the ROI of 3.25.

This ensures the sustainability of 37 new full-time positions in the company.

The project resubmission (13.61) reflects a couple of great achievements in 2016: the FS has elaborated in detail the NanoScreen business plan, the company signed two investment agreements, and had three business partners and two distribution partners.

Moreover, we identified another two major replica-tion opportunities of future joint ventures that can form a new business-industrial ecosystem for online nano-screening. The vision is to reach a unique one-box-system tailored for specific applications, e.g. se-curity, agriculture and sport.

The Phase 2 funding will help us to close the gap from design validation to industrial production and significantly shorten the market entry period.

Multiplex8+

A highly accurate breast cancer diagnostic test for effective personalised treatment and assessment of therapy response are misdiagnosed and then treated inaccurately, put-ting their lives at risk while creaput-ting undue problems for families and healthcare systems. MultiplexDX (a leading Slovak biotechnology company) proposes a personalised and precise diagnostic test for early and late stages of BCa called Multiplex8+. The test combines two IP-protected, revolutionary and multi-plexed cancer diagnostic technologies, visualisation (RNA FISH) and RNA sequencing. By combining the two technologies to eliminate misdiagnosis, Multi-plex8+ defines a specific BCa barcode that suggests a specific personalised treatment, length of therapy and clarifies how likely a BCa patient will or will not benefit from chemotherapy.

There are 2 main objectives of this project: 1. To es-tablish an ISO-15189 accredited laboratory to pro-vide diagnostic services to cancer centres (B2B) and additionally to patients (B2C). A clinical validation on 4,000 tissue samples will be conducted to obtain clinically-based evidence; 2. To build the first success-ful high-value biotech company in Slovakia.

The company has already raised EUR 2.05 million in seed investments and grants and started sales of subproducts generating EUR 300 million in revenues since 2016. MultiplexDX operates in the Comenius University Science Park in Bratislava and consists of 17 team members, 5 business advisors and 7 scien-tific advisors. Our planned accumulated revenues in the first 5 years amount so EUR 305.3 million, gen-erating a net profit of EUR 133 million and repre-senting the ROI of 10.3. Importantly, Multiplex8+ is supported by the entire oncology value chain (pa-tient associations, cancer centres, hospitals, KOLs, insurance companies, pharma/medtech, clinical lab-oratories, biobanks, investors, etc.).

Personal experience

“We applied four times to SME Phase 1 before Multi-plexDX received some venture capital that allowed us to bring our concept to a more developed stage, and so we decided to apply directly to Phase 2 (EIC Accel-erator). We applied to Phase 2 ten times before our project was funded — it was quite a challenging ride!

The EIC Accelerator supported our Multiplex8+ pro-ject due to its contribution to increasing the accura-cy of diagnostics for breast cancer, one of the most widespread types of cancer. The goal of Multiplex8+

is to increase the accuracy of breast cancer diagnostics from today’s 50–70% to 98%. If a large-scale retro-spective clinical validation of Multiplex8+ proves to be successful, the diagnostic test will enter the clinical practice as early as 2023.

It was quite a challenge to gain support and rec-ognition for our project from the entire oncology value chain before submitting the project. We were convinced about the innovation and need to introduce our novel personalised diagnostic, but it was difficult to convince the European Commission about the support from the Slovak innovation ecosystem, even though our ambition is to change breast cancer diag-nostics globally. We believe that after the verification in preclinical tests, Multiplex8+ will help cancer pa-tients not only in Slovakia but also worldwide.

We are incredibly proud of our entire team that helped prepare the proposal. Our success in the competition of nearly 2,000 innovative European projects, assessed by an international committee, confirms that our re-search meets the requirements for global R&D projects.

We recommend finding professionals to help you with the proposal. We were extremely satisfied with the help from a professional H2020 project consulting agency. Persevere and continue to submit over and over again, if you are convinced about your project.

Even if you do not get the funding, writing a good project is an invaluable company strategy exercise and helps you refine your business plan and concepts.”

3.4 SME Projects

Poland

TREG

innovative cell therapy targeting Diabetes Type 1

Coordinator: PolTREG S. A., Medical University of Gdańsk, Professor Piotr Trzonkowski

Link: https://cordis.europa.eu/project/id/830559 Abstract

The main challenge of the project is to prepare and start Phase III of the clinical development of TREG – a ground breaking Type 1 Diabetes (T1D) somatic cell therapy with T-regulatory cells obtained from the pa-tient’s blood. T1D preventions strategies have not yet been successful. The TREG project aims to change it and become the first efficient prevention T1D thera-py. The uniqueness and innovativeness of the treat-ment lies in the reduction of the disease causes, and not only its clinical symptoms which improve the quality of life and the clinical parameters of patients.

The TREG therapy, patented technology, is a re-sponse to the largest, according to the World Health Organisation, global health emergencies of the 21st century – diabetes. In 2014, 422 million people in the world had diabetes compared to 108 million in 1980. It means the global prevalence (age-standard-ised) of diabetes has nearly doubled since 1980 ris-ing from 4.7% to 8.5% in the adult population and will continue to grow. According to the IDF Diabetes Atlas 2017, it is estimated that 7% to 12% of them have type 1 diabetes. While DM2 is more common, it is potentially preventable. The causes and risk factors

for T1D remain unknown and prevention strategies have not yet been successful.

The majority of efforts in the area of T1D treatment are put on the production of insulin preparations or the development of medical devices connected with insulin admission and glucose control. Progress in this area has significant influence on the quality of the patient’s life, but in fact they do not eliminate the causes of the illness.

As a result of the proposed project, PolTREG will start the next stage of clinical trials (Phase III) on the safety and efficacy of the therapy in a broader paediatric population. If successful, the project will accelerate availability of a breakthrough therapy to T1D patients and put PolTREG on a path of business development by a full-scale commercialisation of the innovation.

Personal experience

“PolTREG is amongst the global leaders offering advanced therapy addressing the underlying cause of the newly diagnosed type 1 diabe-tes mellitus. Currently, the treatment with the product developed by the company is only available to those patients who have qualified for clinical trials or are under the so-called hos-pital exemption. The therapy is carried out only at the University Clinical Centre in Gdańsk.

It is a disease-modifying therapy, so we have a real chance to transform the present approach to the treatment of type 1 diabetes. The com-pany completed the phase II clinical study and expects to finalise the clinical study report (CSR) in the next few weeks. We also entered in a dia-logue with EMA under the Scientific Advice pro-cess and we are getting ready for a pre-meeting with FDA, scheduled for this autumn. The next steps include the start of the pivotal study and the marketing authorisation application in Eu-rope. We aim to be able to offer the therapy to the global market in 2025.

We applied with a very clear aim to receive mar-keting authorisation of our therapy. The disease we are working on is the unmet medical need and any progress in the treatment is highly ap-preciated by the community. The added value of being part of the H2020 project is that it is a very ennobling experience. The recipient re-ceives greater attention from potential inves-tors. It makes a difference to the company.”

BacterOMIC

Intelligence for precision therapies against antimicrobial resistance: The first diagnostic panel that probes all the clinically relevant antibiotics at once

Coordinator: BACTEROMIC sp. z o. o., Institute of Physical Chemistry of Polish Academy of Sciences, led by Piotr Garstecki

Link: https://cordis.europa.eu/project/id/881101 Abstract

Automation of pathogen antibiotic resistance tests Antibiotic resistance of pathogens presents an increasing global threat resulting in millions of deaths each year. One of the main reasons for the increasing number of resistant pathogens is the non-optimal application of the antibi-otics. A targeted narrow-spectrum antibiotic application is preferable, but current manual resistance tests are la-borious while available automatic tests evaluate a limited number of antibiotics. The EU-funded BacterOMIC project is developing a fully automated antimicrobial susceptibil-ity testing system for rapid (under 4 hours) identification of efficient antibiotics from the set of all those commonly available for the treatment of certain pathogens. Impor-tantly, the new system allows to identify a combination of several antibiotics for the most efficient treatment of infection. The project involves international collaboration within the EU, and the phase 2 current goal is to optimise the instrumental design and validate the system in clinical trials for future commercialisation.

Objective

In recent years, we have seen a drastic increase in the antibiotic resistance among bacterial pathogens. This is

considered as one of the biggest threats to global health in the current era. The reason behind this is inappropri-ate use of antibiotics – patients are often treinappropri-ated with a non-optimal antibiotic that needs to be changed after few days. The number of resistant microorganisms con-stantly grows due to inappropriate use of antibiotics – patients are often treated with inappropriate drugs that need to be changed after few days if bacteria turn to be resistant. The reason is that current manual antibiotic resistance tests are time-consuming and laborious, while

considered as one of the biggest threats to global health in the current era. The reason behind this is inappropri-ate use of antibiotics – patients are often treinappropri-ated with a non-optimal antibiotic that needs to be changed after few days. The number of resistant microorganisms con-stantly grows due to inappropriate use of antibiotics – patients are often treated with inappropriate drugs that need to be changed after few days if bacteria turn to be resistant. The reason is that current manual antibiotic resistance tests are time-consuming and laborious, while